Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

FDA device recall Z-0982-2019 · posted 2019-03-07 · Terminated

Recall details

Recalling firm

Microbiologics Inc

Reason for recall

Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

Action taken

On about 01/31/2019, Microbiologics notified customers via an "Important Medical Device Correction" letter, sent through email. The letter notified customers of the change in expiration date, instructed customers to update their records with the provided new expiration date, to not use the product after the expiration date, and to complete and return the "MEDICAL DEVICE CORRECTION CUSTOMER RESPONSE FORM." For questions, contact Technical Support at 1-320-229-7064 or techsupport@microbiologics.com.

Root cause

Error in labeling

Status

Terminated

Product code

PMN

Quantity affected

704 units

Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distributio

Date initiated

2019-01-31

Date posted

2019-03-07

Date terminated

2020-06-09

Location

Saint Cloud, MN